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Experimental study and application of PaMZ/BMP-2 thermosensitive gel microsphere controlled release complex targeting local lesions of spinal tuberculosis

Experimental study and application of PaMZ/BMP-2 thermosensitive gel microsphere controlled release complex targeting local lesions of spinal tuberculosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400095016
Enrollment
Unknown
Registered
2024-12-31
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal tuberculosis

Interventions

PaMZ/mbp-2Thermosensitive gel microsphere complex system implantation group:After clearing the spinal tuberculosis focus, the PaMZ/BMP-2 thermosensitive gel microsphere complex was directly placed int
Routine spinal tuberculosis focus clearance group:Routine excision of spinal tuberculosis focus

Sponsors

The Second Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with clinically confirmed diagnosis of spinal tuberculosis, non active, and planning to undergo surgical treatment; 2. Age = 18 years old; 3. The American Society of Anesthesiologists (ASA) classification is I-III. 4. Those who voluntarily participate in this study and sign an informed consent form. 5. Surgical indications for spinal tuberculosis: (1) Local stubborn pain caused by spinal tuberculosis, poor quality of life, and no significant relief of symptoms after standardized anti tuberculosis treatment. (2) Under the standard anti tuberculosis treatment, the stubborn pain symptoms are not relieved, and the tuberculosis focus and abscess increase and progress. (3) The standard anti tuberculosis treatment for spinal tuberculosis still persists or the spinal damage shows an expanding trend. (4) The spinal tuberculosis focus pus, tuberculous granulation tissue, caseous necrotic substances, dead bones, etc. oppress the spinal cord and cause sensorimotor disorders (5) Tuberculosis focus leads to destruction of local stability of the spine, even local kyphosis and intractable pain. (6) After the cure of spinal tuberculosis, obvious kyphosis was left, accompanied by local pain or delayed paralysis.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of spinal surgery or combined with other spinal diseases. 2. Patients with severe functional impairment of important organs such as the heart, liver, brain, lungs, and kidneys who cannot tolerate surgery. 3. Pregnant or lactating women, or patients with severe mental illness.

Design outcomes

Primary

MeasureTime frame
Blood routine ;Erythrocyte sedimentation rate;C-reactive protein ;Visual Analogue Scale;Oswestry Disability Index;Cobb angle;Anti-tuberculosis Antibodies;Quality of Life Score;Neurological Function Status;Vertebral Subsidence Rate;Discontinuation Rate;Cure Rate;Recurrence Rate;

Countries

China

Contacts

Public ContactCao Guang Ru

The Second Affiliated Hospital of Zunyi Medical University

caoguangru2003@163.com+86 135 1180 1063

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026